Following the publication of the report on innovation in the regulation of healthcare by the Medicines and Healthcare Products Regulatory Agency (MHRA), the BioIndustry Association (BIA) urges the U.K. government to implement a properly funded and reimbursed Earlier Access to medicines Scheme (EAS), which the group makes its number one recommendation.
“I am pleased that the expert group wants the European Medicines Agency to launch a call for adaptive licensing at the earliest opportunity so companies could put forward pilot products, and that the group proposes the idea of adopting a new breakthrough designation for new therapies both at a U.K. and E.U. level,” said Steve Bates, BIA’s CEO.
“In just a year since new rules were put in place for the development of treatments in the U.S., 32 drugs have been granted Breakthrough Designation by the FDA,” he said. “This designation has rapidly sped up the process for drugs to become available for patients who need them. These have been for products where there is a desperate need for new drugs, for example in multiple myeloma, cystic fibrosis, hepatitis C, acute heart failure and Duchenne muscular dystrophy. Two drugs with Breakthrough Designation status have already been approved by the FDA.
“If U.K. patients are to benefit from the most promising new drugs and U.K. biotech companies are to develop those therapies here rather than overseas, we need a similar Breakthrough Designation scheme here,” said Bates. “As well as holding the potential to significantly accelerate such treatments to those patients who need them, Breakthrough Designation has had a positive effect on the companies developing the products and on the investment community’s perception of those companies.